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Clinical Trials/NL-OMON54619
NL-OMON54619
Completed
Phase 4

Paravertebral catheter versus Epidural analgesia in Minimally Invasive Esophageal Resection: a randomized controlled multicenter trial (PEPMEN trial) - PEPMEN trial

niversitair Medisch Centrum Utrecht0 sites199 target enrollmentTBD
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Conditionsesophageal cancer100179901001799110017998

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
esophageal cancer
Sponsor
niversitair Medisch Centrum Utrecht
Enrollment
199
Status
Completed
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
March 21, 2024
Last Updated
2 years ago
Study Type
Interventional

Investigators

Sponsor
niversitair Medisch Centrum Utrecht

Eligibility Criteria

Inclusion Criteria

  • •The study population consists of patients who are scheduled to undergo elective
  • •minimally invasive esophagectomy with two\-field lymphadenectomy, gastric
  • •conduit reconstruction, and intrathoracic anastomosis (i.e. Ivor Lewis
  • •procedure).

Exclusion Criteria

  • •\- ASA \>III / severe comorbidity
  • •\- Coagulation disorders that prohibit epidural analgesia according to the
  • •Nederlandse Vereniging voor Anesthesiologie (NVA) guideline \*Neuraxisblokkade
  • •en antistolling\*
  • •\- Other contraindications for epidural analgesia
  • •\- Allergy to local anesthetics
  • •\- Ongoing opioid use (i.e. any opioid) prior to esophagectomy (i.e. \>3 months
  • •calculated until the day of esophagectomy)
  • •\- Renal failure, i.e. eGFR \< 50
  • •\- Unable to complete questionnaires in Dutch

Outcomes

Primary Outcomes

Not specified

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